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Completed

NCT Number: NCT02339688

Psychometric Properties Mobility Measures MS

Current study will investigate the quality (psychometric properties) and clinical utility of several mobility measures, according to disability level. Therefore, several aspects will be inquired:

* Was there an effect of rehabilitation * Is the measure able to detect change over time? And thus the change exceed measurement error and is it clinically important (responsiveness) * Does the measure assess what it claims to measure (validity) * Is the measure able to differentiate all performances of the patients, inclusively the very good and very bad performances (floor and ceiling effects) * Does the measure gives similar results under consistent test conditions on another testing day (reliability) Worldwide, theoretical approaches to physical therapy and rehabilitation in Multiple Sclerosis often appear significantly different. Since the present research protocol will be performed at different centers across European countries (and US sites), this multi-center study can additionally be applied for mapping the volume and content of rehabilitation, as well as the differential impact of diverse rehabilitation approaches and training volume on mobility, for several disability levels.

Some health-economic analyses will be performed to examine what the approximate cost of rehabilitation compared to effects is and what drivers of costs are (setting, equipment, staff).

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University

Diepenbeek, 3590, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of MS according to McDonald criteria24,
  • Expanded Disability Status Scale25 (EDSS) ≥ 2 and ≤ 6.5 as determined by neurologists or trained clinician
  • no relapse within the last month
  • no changes in disease modifying treatment and no corticoid-therapy within the last month
  • receive at least 10 sessions of physical therapy (in- or outpatient rehabilitation), with a maximum duration of 3 months

Exclusion criteria

  • other medical conditions interfering with mobility (e.g. stroke, pregnancy, fractures, …)
  • other neurological impairments with permanent damage (stroke, Parkinson, …)
  • MS-like syndromes such as neuromyelitis optica
  • not able to understand and execute simple instructions

Treatment and study plan

conventional MS rehabilitation

Other

assessment pre and post conventional MS rehabilitation

Primary outcomes

  1. Timed 25-Foot Walk test (T25FW)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  2. Timed up and go (TUG), TUGcognitive

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  3. Two minute walk test (2MWT)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  4. Four Square Step Test (FSST)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  5. 5 repetition sit-to-stand test (5STS-test)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  6. Modified 5 repetition sit-to-stand test (mod 5STS-test)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  7. Rivermead Mobility Index (RMI)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  8. Multiple Sclerosis Walking Scale-12 (MSWS-12)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  9. Performance Scale mobility (PS-mob)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

Secondary outcomes

  1. Timed Up and Go, manual

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  2. Berg Balance Scale (BBS)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  3. Dynamic Gait index (DGI)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  4. Activities-specific Balance Confidence Scale (ABC)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  5. Trunk Impairment Scale, modified Norwegian version (TIS-modNV)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

  6. International Physical Activity Questionnaire (IPAQ)

    Time frame: day 1 and at the end of the rehabilitation, an expected average of three months

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • Charles University, Czech Republic
  • Cleveland Mellen MS Center
  • Clinical center Belgrado
  • Danish MS Hospitals, Haslev and Ry
  • De Mick
  • Dept Neurological Rehabilitation Reha Zentrum Münster Gröben
  • Eugenia Epalza Rehabilitation Center, Bilbao, Spain
  • Fondazione Don Carlo Gnocchi ETS
  • Haukeland University Hospital
  • Italian Multiple Sclerosis Foundation
  • MS Rehabilitation Center Borne Sulinowo
  • MS-Senteret Hakadal
  • Masku Neurological Rehabilitation Center
  • National MS Center Melsbroek
  • Queen's University
  • Quellenhof
  • Revalidatie & MS Centrum Overpelt
  • Sheba Medical Center
  • Shepherd Center, Atlanta GA
  • St. Louis University
  • University of Colorado, Denver

Registry information

Official study title

Psychometric Properties of Mobility, Beyond Walking Speed, in Multiple Sclerosis: a Multi-center Study.

Acronym: MCS-III-MOB

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jan 15, 2015
Registry last updated
Jun 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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